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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Young Innovations

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Device Problem Device Operational Issue (2914)
Patient Problem Radiation Exposure, Unintended (3164)
Event Type  malfunction  
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Manufacturer (Section G)
Young Innovations
4321 goshen road
fort wayne IN 46818
Manufacturer Contact
tammy shiffler
4321 goshen road
fort wayne, IN 46818
MDR Report Key7785923
Report NumberCOR18001357-000
Device Sequence Number1
Product Code EHD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2018
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation?
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No Answer Provided
Type of Device Usage Invalid Data